美国FDA《食品保护计划》(珠海局翻译)20080408
fda对预制食品的标准要求
fda对预制食品的标准要求预制食品是指在生产过程中经过加工、包装、保存等环节后供消费者食用的食品，如方便食品、速冻食品、即食食品等。
为了保障消费者的食品安全健康，美国食品药品管理局（FDA）对预制食品制定了一系列的标准要求。
1. 食品成分要求：FDA要求预制食品的成分应当安全、合法，并标明在包装上。
对于常见的过敏原物质，如麦麸、坚果、牛奶、鸡蛋等，如果预制食品成分中含有这些过敏原物质，必须在包装上清晰标注并提醒消费者。
2. 卫生要求：FDA要求预制食品在生产过程中要严格遵守卫生要求，确保食品不受到细菌、病毒等污染。
生产企业必须建立完备的卫生管理制度，包括设立清洁区域和脏区域、员工必须严格按照卫生操作规程操作、设备设施要保持清洁等。
3. 标签要求：预制食品的包装上必须标明食品的名称、成分表、保质期、生产日期等信息。
此外，食品的标签上还要包含营养成分表，包括卡路里、脂肪含量、蛋白质含量、钠含量等重要信息。
对于低脂、低糖、低钠等特殊食品，必须在标签上进行特殊标注。
4. 机械加工要求：对于需要经过机械加工的预制食品，FDA对机械设施的设计和操作要求非常严格。
美国国家标准协会（ANSI）出台了一系列与机械操作和安全相关的标准，包括操作人员要接受相关培训、操作设备要符合安全标准、设备要定期维护保养等等。
5. 添加剂限制：FDA对预制食品中添加剂的使用也有一系列限制要求。
例如，用于增加食品味道和口感的人工香精和调味剂，必须使用FDA认可的安全食品添加剂，并符合使用的最大限量标准。
6. 产品检验：FDA要求预制食品生产企业建立自我检验机制，进行定期的食品质量检验，包括对食品成分的检测、微生物检测、重金属检测等等。
对于特定食品，FDA也会进行不定期的食品抽样检验。
7. 保质期标准：预制食品的保质期是指食品在正常储存条件下在失去食品质量的最大时间。
FDA对不同类型的预制食品的保质期也有严格的规定，生产企业必须按照规定在包装上标明保质期，并确保在保质期内食品的质量不会明显下降。
Food_Defense_Plan美国农业部《食品防护计划.
U.S. Department of AgricultureFood Safety and Inspection ServiceD EVELOPING A F OOD D EFENSE P LANFORM EAT AND P OULTRYS LAUGHTER AND P ROCESSING P LANTSJ ANUARY 2007B Y COMPLETING PAGES 13 THROUGH 16 IN THIS GUIDE, SLAUGHTER AND PROCESSING PLANTS WILL HAVE A F OOD D EFENSE P LAN FOR THEIR OPERATIONWhat is Food Defense?Food defense is not the same as food safety. Food defense focuses on protecting the food supply from intentional contamination, with a variety of chemicals, biological agents or other harmful substances by people who want to do us harm. These agents could include materials that are not naturally-occurring or are not routinely tested for. Anattacker’s goal might be to kill people or disrupt our economy. Intentional acts are generally not reasonable and are hard to predict.Food safety addresses the accidental contamination of food products during processing or storage by biological, chemical or physical hazards. The main types of food safety hazards are microbes, chemicals and foreign objects. This unintentional contamination of food products can be reasonably anticipated based on the type of processing. This principle is the foundation of the Hazard Analysis Critical Control Point (HACCP process used to ensure food safety.Note that because of the differences between food safety and food defense your plant’s HACCP plan should not be used as a substitute for a Food Defense Plan because not all of the Critical Control Points will be the same. However, creating a Food Defense Plan does not require development of another HACCP-type document. Some of the information you may use to create a plan will possibly exist in your HACCP plan, SSOPs, and other documents such as emergency response procedures. Make sure to consult these documents for information. There is no need to “reinvent the wheel” when developing your Food Defense Plan.Why Develop a Food Defense Plan?A Food Defense Plan helps you identify steps you can take to minimize the risk that food products in your establishment will be intentionally contaminated or tampered with.A plan increases preparedness. Although the plan should be in place at all times, it may be particularly helpful during emergencies. During a crisis, when stress is high and response time is at a premium, a documented set of procedures improves your ability to respond quickly. A Food Defense Plan will help you maintain a safe working environment for your employees, provide a quality product to your customers, and protect your bottom line.To help plants, USDA’s F ood Safety Inspection Service (FSIS has created this guide to assist you in developing a cost-effective Food Defense Plan for your facility. This guide was developed in consultation with very small, small and large meat and poultry processing establishments in an attempt to ensure that the information presented is beneficial, practical and achievable.By using this guide, you will be able to develop a food defense plan specific to your facility. Complete Pages 13 through 16 and you will have your functional plan. Keep in mind that not all of the guidance contained in this document may be appropriate or practical for every FSIS regulated facility. FSIS recommends you review the guidance and assess which preventive measures are suitable for your operation. You should determine the most cost-effective way to achieve food defense goals based on your plant’s situation. It is important to remember thatthere is no “one size fits all” approach to creating your Food Defense Plan. The plan can be as long or as short as is appropriate for your operation.Who Might Adulterate a Food Product?The table below lists some examples of the types of individuals who might be motivated to adulterate food products. You should contact your local law enforcement community for additional information about potential local threats to your facility.Examples of Potential Internal and External ThreatsInternal ExternalDisgruntled employee Organized terrorist or activist groupsCleaning crew Truck drivers (shipping and receivingContractors Contractors Temporary employees Suspect suppliersMembers of terrorist groups posing as employees VisitorsIndividuals motivated to attack a plant/product that do not have authorized access are considered to be intruders. Another threat may come from an internal source, such as disgruntled employees and other insiders, who typically know what procedures are followed in the plant and often know how to bypass many security controls that would detect or delay an outside intruder.Steps in Developing a Food Defense PlanFSIS recommends using the following three steps when developing a Food Defense Plan. If you follow and complete these steps and use the forms provided as a template, you will have developed a food defense plan for your facility.Should you need help using or have questions about this guidance, please contact the FSIS Technical Service Center at 1-800-233-3935 or TechCenter@.Step 1 – Conduct a Food Defense AssessmentBegin by choosing a person or team to be responsible for the security of your plant. The team or responsible person will answer the questions in the assessment below to help you understand which parts of your facility may be more vulnerable. When completing this assessment remember to consider both potential internal and external threats. The results of the assessment should be kept confidential so that they do not provide a roadmap for future attacks.To use the following Facility Food Defense Assessment, read each question and check the response that best describes how your process operates. Keep in mind that not all questions will be appropriate for all facilities. If a question does not apply, check“N/A”. For example, if your plant only conducts processing activities, then questions that ask about live animals or sla ughter operations would not apply. A “Yes” response forevery question is desirable but not expected. A “No” answer on a question does not necessarily mean there is a seriousproblem with security at your plant. A “No” should trigger some thinking about whether additional security measures are needed. Some questions provide a website address for additional information that might help you formulate your plan.Outside Security1. What food defense measures does your plant have in place for the exterior of the building?Yes No N/A Are the plant’s grounds secured to prevent entry by unauthorized persons (e.g., bylocked fence, gate or entry/exit doors?Is there enough lighting outside the building to properly monitor the plant atnight/early morning?Do emergency exits have self-locking doors and/or alarms?2. Are the following secured with locks, seals, or sensors when unattended (afterhours/weekends to prevent entry by unauthorized persons?Yes No N/A Outside doors and gates?Windows?Roof openings?Vent openings?Trailer (truck bodies?Tanker truck hatches?Railcars?Bulk storage tanks/Silos?3. Does your facility have food defense procedures for people and/or vehicles entering the plantand/or parking in your lot?Yes No N/A Does the property have a controlled or guarded entrance?Are employee vehicles identified using placards, decals, or some other form ofvisual identification?Are authorized visitor/guest vehicles identified using placards, decals, or someother form of visual identification?General Inside Security4. Does your facility have food defense measures inside the establishment?Yes No N/A Is there an emergency lighting system in the facility?Does your plant have monitored security cameras (CCTV?Does your plant have an emergency alert system that is tested regularly?Are the locations of controls for emergency alert systems clearly marked?Are all restricted areas (i.e., areas where only authorized employees have accessclearly marked?Are visitors, guests, and other non-employees (e.g., contractors, salespeople,truck drivers restricted to non-product areas unless accompanied by anauthorized employee?Does local law enforcement (including the fire department have up-to-datecopies of facility layouts/blueprints?Are procedures in place to check toilets, maintenance closets, personal lockers,and storage areas for suspicious packages?Do you regularly take inventory of potentially dangerous tools and utensils (e.g.,knives?Do you regularly take inventory of keys to secured/sensitive areas of thefacility?Are ventilation systems constructed in a manner that provides for immediateisolation of contaminated areas or rooms?5. Are the controls for the following systems restricted (e.g., by locked door/gate or limitingaccess to designated employees to prevent access by unauthorized persons? (Helpful information is provided at the following website: /niosh/bldvent/2002-139.htmlYes No N/A Heating, Ventilation, and Air Conditioning systems?Propane Gas?Water systems?Electricity?Disinfection systems?Clean-in-place (CIP systems or other centralized chemical systems?6. Does your plant collect and analyze samples in-house for microbiological, chemical orphysical hazards?YesNo [Go to Question 8]7. Which of the following food defense procedures does your facility have in place for its in-plant laboratory facilities, equipment, and operations?Yes No N/A Is access to the in-plant laboratory facility restricted to authorized employees?(e.g., by locked door, pass card, etc.Is a procedure in place to control receipt of samples received from otherestablishments?Is a procedure in place to receive and securely store reagents?Is a procedure in place to control and dispose of reagents?8. Does your facility use a computer system to monitor processing operations?YesNo [Go to Question 10 under Slaughter and Processing Security]9. Does your facility have food defense procedures in place for its computer systems?Yes No N/A Is the access to the system password-protected? (Helpful information isprovided at the following website: /~policies/pw-security.htmlAre firewalls built into the computer network?Is the system using a current virus detection system?Slaughter and Processing Security10. Which of the following food defense procedures does this facility have in place for itsslaughter and processing operations?Yes No N/A Is access to product production/slaughter and holding pen areas restricted toestablishment employees and FSIS inspection personnel only?Are lines that handle and transfer products, water, oil, or other ingredientsmonitored to ensure integrity?Are packages of ingredients examined for evidence of tampering before use?Is access to in-plant irradiation equipment and materials restricted?Are records maintained to allow easy trace-back of raw materials to suppliers?Are records maintained so as to allow easy trace-forward of finished products tovendors?Storage Security11. Which of the following food defense procedures does your facility have in place for itsstorage areas?Yes No N/A Is access to raw product storage areas, including cold and dry storage areasrestricted (e.g., by locked door/gate or other to designated employees?Is an access log maintained for raw product storage areas?Is access to non-meat ingredient storage areas restricted to designatedemployees only?Is an access log maintained for non-meat ingredient storage areas?Is access to finished product storage areas restricted to designated employees?Is access to external storage facilities restricted to designated employees only?Do you conduct regular security inspections of storage facilities (includingtemporary storage vehicles?Do you maintain records on facility security inspections results?Is the inventory of restricted ingredients (i.e., nitrites, etc checked against theactual use of such ingredients on a regular basis?Are product labels and packaging held in a controlled manner to prevent theftand misuse?Is the inventory of finished products regularly checked for unexplainedadditions and withdrawals from existing stock?12. Which of the following food defense procedures does your facility have in place for thestorage of hazardous materials/chemicals such as pesticides, industrial chemicals, cleaning materials, sanitizers, and disinfectants?Yes No N/A Is the access to inside and outside storage areas for hazardousmaterials/chemicals such as pesticides, industrial chemicals, cleaning materials,sanitizers, and disinfectants restricted in some manner to allow use bydesignated employees only?Is a regular inventory of hazardous materials/chemicals maintained?Are discrepancies in daily inventory of hazardous materials/chemicalsimmediately investigated?Are the storage areas for hazardous materials/chemicals constructed and safelyvented in accordance with national or local building codes?Is a procedure in place to receive and securely store hazardous chemicals?Is a procedure in place to control disposition of hazardous chemicals?Shipping and Receiving Security13. Does your facility have food defense procedures in place for its shipping and receivingoperations? (Helpful information is provided at the following website:/oa/topics/transportguide.htmYes No N/A Are trailers on the premises maintained under lock and/or seal when not beingloaded or unloaded?Are tanker trucks on the premises maintained under lock and seal when notbeing loaded or unloaded?Is the loading and unloading of vehicles transporting raw materials, finishedproducts, or other materials used in food processing closely monitored?14. Does your facility have food defense procedures in place for handling outgoing shipments?Yes No N/A Are outgoing shipments sealed with tamper-evident seals?Are the seal numbers on outgoing shipments documented on the shippingdocuments?Are tanker trucks and/or rail cars inspected to detect the presence of anymaterial, solid or liquid, in tanks prior to loading liquid products?Do you keep records of the above-referenced inspections of tanker trucksand/or rail cars?Are chain-of-custody records maintained for tanker trucks and/or rail cars?15. Which of the following food defense procedures does your facility have in place for handlingincoming shipments?Yes No N/AIs access to loading docks controlled to avoid unverified or unauthorizeddeliveries?Is advance notification from suppliers (by phone, e-mail, or fax required forall incoming deliveries?Are suspicious alterations in the shipping documents immediatelyinvestigated?Are all deliveries checked against the roster of scheduled deliveries?Are unscheduled deliveries held outside facility premises pending verification?Are off-hour deliveries accepted?If off-hour deliveries are accepted, is prior notice of the delivery required?If off-hour deliveries are accepted, is the presence of an authorized individual to verify and receive the delivery required?Are less-than-truckload (LTL or partial load shipments vehicles checked? Are incoming shipments of raw product, ingredients, and finished products required to be sealed with tamper-evident or numbered seals (and documented in the shipping documents? Are these seals verified prior to entry?Do you check incoming shipments of raw product, ingredients, and finished products at the receiving dock for evidence of tampering?Is the FSIS Public Health Veterinarian notified immediately when animals with unusual behavior and/or symptoms are received?Are the feed and drinking water supplies for live animals protected from possible intentional contamination?Are transportation companies selected with consideration of the company’s ability to safeguard the security of product/animals being shipped?Do the transportation companies perform background checks on drivers and other employees who have access to product/animals?Have your ingredient suppliers taken steps to strengthen food defense in theirfacilities and during transport?When choosing your compressed gas vendor do you consider whether or notthey have implemented food defense measures?When choosing your packaging materials and labels vendor do you considerwhether or not they have implemented food defense measures?16. Does this facility allow returned goods, including returns of U.S. exported products, to enterthe plant?YesNo [GO Question 18 under Water and Ice Security]17. Which of the following food defense procedures does this facility have in place for returnedgoods?Yes No N/A Are all returned goods examined at a separate designated location in the plantfor evidence of possible tampering before salvage or use in rework?Are records maintained of returned goods used in rework?Does the plant follow the procedures outlined in FSIS Directive 9010.1 forreturn of U.S. exported products? (Helpful information is provided at thefollowing website:/opped/rdad/fsisdirectives/9010-1.pdfWater and Ice Security18. Which of the following food defense procedures does your facility have in place for its waterand ice supply? (Helpful information is provided at the following website:/region1/eco/drinkwater/pdfs/drinkingH2Ofactsheet.pdfYes No N/AIs access to water wells restricted? (e.g., by locked door/gate or limitingaccess to designated employeesIs access to ice-making equipment restricted?Is access to ice storage facilities restricted?Is access to storage tanks for potable water restricted?Is access to water reuse systems restricted?Are potable water lines periodically inspected for possible tampering?(i.e., visual inspection for physical integrity of infrastructure etc.?Are non-potable water lines inspected for possible tampering (i.e., visualinspection for physical integrity of infrastructure, connection to potable lines,etc.?Have arrangements been made with local health officials to ensure immediatenotification of the plant if the potability of the public water supply iscompromised?Mail Handling Security19. Which of the following food defense procedures does this facility have in place to ensuremail handling security?Yes No N/AIs mail handling activity conducted in a separate room or facility away fromin-plant food production/processing operations?Are mail-handlers trained to recognize and handle suspicious pieces of mailusing U.S. Postal Service guidelines? (Helpful information is provided at thefollowing website: /news/2001/press/serviceupdates.htmPersonnel Security20. Which of the following food defense procedures does your facility have in place for ensuringthat personnel adhere to the security requirements?Yes No N/A Are background checks conducted on all employees and contractors (bothpermanent and seasonal who will be working in sensitive operations?Do all plant employees receive training on security procedures as part of their orientation training?Are employees, visitors, and contractors (including construction workers, cleaning crews, and truck drivers identified in some manner at all times while on the premises?Does your plant control access by employees and contractors entering the plant during working hours (e.g. coded doors, receptionist on duty, swipe card, etc.?Does your plant control entry of employees and contractors into the plant during non-working hours (e.g. access limited by key card or code number? Does your plant have a way to restrict temporary employees and contractors (including construction workers, cleaning crews, and truck drivers to areas of the plant relevant to their work?Is there some manner to identify personnel with their specificfunctions/assignments/departments (e.g., corresponding colored uniforms?Is an updated shift roster (i.e., who is absent, who the replacements are, and when new employees are being integrated into the workforce kept by management for each shift?Does your plant allow personal items within production areas?Do you inspect employee lockers?Are employees and/or visitors restricted as to what they can bring (cameras,etc. into the plant?Are employees prohibited from removing company-provided clothing orprotective gear from the premises?Step 2 – Develop a Food Defense PlanNow that you have identified some areas outside or inside your plant, or procedures used in daily operations that may be more vulnerable than others, you will need to identify cost-effective preventive actions that can be taken to minimize those vulnerabilities.At a minimum, your Food Defense Plan should address:•processing security•storage security•shipping and receiving security•water and ice securitySome examples of potential vulnerabilities and food defense measures are listed below. Additional defense measures may be found in trade association guidance material.Processing SecuritySample Vulnerabilities Potential Food Defense MeasuresThreat agents introduced at critical points in the process Restrict access at critical operations to employees that receive additional training and/or background investigations. Increase employee food defense awareness. Monitor process at ballast tanks,grinding/emulsification of meat and poultry products, meat storage coolers, and solution injection. Routinely calibrate equipment such as temperature gauges, pH meters, and scales.Access from retail shop to critical areas Monitor customer activity and restrict access to receiving,storage, processing and shipping areas.In-house analytical laboratory access unsecured Utilize interior access controls to restrict all but authorizedand trained personnel.Temporary employees with access to critical process areasTrain permanent employees on food defense to raise their food defense awareness. Consider the use of color-codeduniforms, hats, jackets, etc. (e.g. blue uniforms only in raw product area.Storage SecuritySample Vulnerabilities Potential Food Defense MeasuresThreat agents placed in non-meat ingredients (spices, additives and non-food items (disinfectants, cleaners, packaging materials Threat agents placed in combo bins containing trim, variety meats, or parts destined for further processing Secure access toall points of building entry during non-operating hours. Keep storage areas locked and limit access based on job function. Monitor access to storage areas by issuing keys toonly those who should have access. Consider use of logs for inventory material control. Make periodic checks of inventories and examine integrity of packaging.Cleaning supplies, pest control chemicals and other hazardous material may become agents. Secure access to all points of building entry during non-operating hours. Control use and storage of hazardous materials by locking in area away from other inventory. Allow access to only those who should have access.Shipping and Receiving SecuritySample Vulnerabilities Potential Food Defense Measures Unscheduled deliveries Purchase materials only from recognized vendors. Acceptreceipt of only scheduled deliveries. Inventory packagesagainst manifest and order forms and examine packageintegrity. Request that vendors ship materials in tamper-evident packaging.Products shipped in unsecured trucks, or multiple deliveries per shipment (less-than-truckload All truck shipments should be secured by use of tamper-evident seals. Drivers should be trained regarding proper shipping documentation.Truck drivers on dock with access to plant Have drivers sign in and escort them at all times whileinside the facility.Water and Ice SecuritySample Vulnerabilities Potential Food Defense MeasuresThreat agents are put into well water Lock well house and restrict access.Secure ice storage facilities.Threat agents are introduced into ice used inemulsification or other applications.Threat agents placed in water supply used toSecure potable water lines and storage tanks.prepare marinadeUsing the above information, you are now ready to complete your plan. After completing the following pages you will have successfully developed a Food Defense Plan for your specific operation. Congratulations!Food Defense Planfor(Your plant’s name ______________________________________________ Continue with Step 2 and Step 3. Once completed, this will become your Food Defense Plan. Review the assessmen t questions listed in Step 1 to find your “No” answers to determine if changes should be made to your current practices. Copy any potential vulnerabilities you have identified into the second column of the table below and then list what food defense measures you plan to use to reduce them. You may find suggested defense measures in the previous table or from guidance through your trade association.Area Identified Vulnerability Planned Defense Measure to Counter VulnerabilityOutside SecurityInside SecuritySlaughter/Processing Security Storage SecurityShipping/Receiving Security Water/Ice Security Personnel SecurityMail Handling SecurityStep 3 – Implement the Food Defense PlanOnce you have a written Food Defense Plan, these questions will help you to ensure that it is functional and up-to-date.Yes No N/A Is there a designated person or team to implement, manage and update the FoodDefense Plan?Have appropriate personnel been trained in food defense?Do you conduct regular food defense drills?Is the Food Defense Plan reviewed (and revised if necessary periodically?Are the details of food defense procedures kept confidential?Is the emergency contact information for local, state, and federal governmenthomeland security authorities and public health officials included in the fooddefense plan? (Helpful information is provided at the following website: Statecontact list: /homeland/contactmap.htmlIs the contact information reviewed and updated regularly?Have you or someone in your plant initiated contact with these authorities?Are procedures for responding to threats of product contamination included in the plan?Are procedures for responding to actual incidents of product contamination detailed in the plan? (Helpful information is provided at the following website:/agriculture/security/fsig.htmlDoes the plan have procedures to ensure that adulterated or potentially harmful products are held at the plant?Does the plan have procedures for safe handling and disposal of contaminated products according to your local EPA authorities?Are employees encouraged to report signs of possible product contamination, unknown or suspicious persons in the facility, or breaks in the food defense system?Does the plan contain evacuation procedures? (Helpful information is provided at the following website: /dep/evacmatrix/index.htmlAre procedures in place to restrict access to the facility to authorized personnel only during an emergency?Does the facility have a documented recall plan that is updated regularly and ensures the segregation and proper disposition of recalled products?As discussed above, key elements of effective plan implementation include assigning responsibilities, training staff, conducting drills, developing contact lists, and checking your recall plan.Developing a Food Defense Plan for Meat and Poultry Slaughter and Processing Plants Assigning Responsibilities Individual employee’s food defense responsibilities should be defined and documented in your plan. Assign overall responsibility for food defense to a single employee, if possible, who has an understanding of the security requirements. Staff Training Train staff in all provisions of the plan. The purpose of food defense awareness training is to ensure your employees know their responsibilities. Training should address access control procedures, access to restricted areas, protecting critical components, and procedures for reporting suspicious activities. Understanding the threat of intentional adulteration and the potential consequences should help employees consistently execute preventive measures, increasing the overall effectiveness of the plan. Encourage the “neighborhood watch” concept employees can be your “eyes and ears”. Quarterly Plan Testing Conduct drills at least quarterly to test and verify the effectiveness of the plan. Some examples of testing or drills might include checking the status of entry ways that are to be locked; checking for any abuse of employee conduct by bringing personal items into processing area; checking to see if hazardous material inventory records are being maintained; etc. Document findings in the following table and then list corrective action to prevent from occurring again. Corrective Action Taken Date Action Taken Date Area Tested Results Signature Signature Food Defense Plan Assessment and Revision Review your plan and revise it, as needed, at least annually or when there is a change in your process. You may need to revise the plan to address changing conditions such as adding a new product line; changing suppliers; contracting out process; adding a new technology; etc. Record the fact that you have done so in the space below. Date Reason for Assessment Signature 15。
食品过敏原标识及消费者保护法案
Smith Business Services, LLC19 Wintergreen Avenue East, Edison, New Jersey 08820, U.S.A. Phone: 908-769-7538, Fax: 908-769-4890通知0510信息翻译和提供：DAVID SHI美国FDA代理人北京陆桥质检认证中心驻美办事处代表美国Smith Business Services, LLCNovember 6, 2005FDA于2004年2月颁布了《食物过敏原标识和消费者保护法案 – 2004》，并于2005年10月5日发布了有关食物过敏原，以及针对该法案的一些问题和解答。
《食物过敏原标识和消费者保护法案 – 2004》的生效日期为2006年1月1日。
由于该法案对很多在美国消费的包装食品，包括进口美国的包装食品，具有一定的影响，所以我们将FDA的这份最终指导文件译成中文，以期使中国的食品企业和相关人员了解该法规的规定和要求，并能采取适当的应对措施。
本译文仅供参考。
本最终指导的原文请见：/~dms/alrguid.html。
如需要进一步的信息，请及时与我们联系。
David ShiVice PresidentSmith Business Services, LLC19 Wintergreen Avenue EastEdison, New Jersey 08820USA.Phone: 908-769-7538Fax: 908-769-4890E-mail: david@Smith Business Services, LLC19 Wintergreen Avenue East, Edison, New Jersey 08820, U.S.A. Phone: 908-769-7538, Fax: 908-769-4890工业指导有关食物过敏原及《食物过敏原标识及消费者保护法案 – 2004》的问题和解答最终指导有关对本文的评论和建议，可以随时提交给Division of Dockets Management (HFA - 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.有关对本文的问题，请通过电话：301-436-2371，或e-mail: Rhonda.kane@与食品安全和应用营养中心（Center for Food Safety and Applied Nutrition，CFSAN）的Rhonda R. Kane联系。
食品防护计划出口食品追溯制度
食品防护计划出口食品追溯制度英文回答：The Food Safety Modernization Act (FSMA) was signedinto law by President Obama on January 4, 2011. FSMA is the most sweeping reform of our food safety laws in more than 70 years. It gives the Food and Drug Administration (FDA) new authorities to prevent foodborne illness and to respond more quickly to foodborne illness outbreaks.One of the key requirements of FSMA is the establishment of a food traceability system. This system will allow FDA to track food products from farm to fork, so that they can more quickly identify and remove contaminated products from the marketplace.The FDA has proposed two different approaches to traceability:Enhanced traceability: This approach would requirefood companies to keep track of where their products are going and where they came from. This would allow FDA to trace food products back to their source and forward to their destination, which would help to identify the source of contamination and prevent contaminated products from reaching consumers.Product tracing: This approach would require food companies to keep track of where their products are going, but not necessarily where they came from. This would allow FDA to trace food products forward to their destination, but not back to their source.The FDA is currently considering comments on these proposed approaches. The final rule on traceability is expected to be issued in 2019.中文回答：食品安全现代化法案 (FSMA) 于 2011 年 1 月 4 日由奥巴马总统签署成为法律。
食品安全法英文版USDA美国农业部翻译
食品安全法英文版USDA美国农业部翻译Food Safety Law USDA Translation: Ensuring Safe and Healthy Food SupplyThe Food Safety Law is a crucial document that guides the regulatory framework for food production, processing, and distribution in the United States. It is a comprehensive law that outlines the responsibilities of the government, food producers, and consumers in ensuring that the food supply is safe, healthy, and reliable.The United States Department of Agriculture (USDA) is responsible for implementing and enforcing the Food Safety Law. As part of its duties, the USDA translates the law into various languages to ensure that it is accessible to a wider audience, including those whose first language is not English.The USDA's translation of the Food Safety Law into English is essential for several reasons. First, it ensures that all stakeholders are aware of their roles and responsibilities in the food production chain. By providing clear and concise information, the USDA translation helps to reduce the risk of foodborne illnesses and other health hazards caused by unsafe food practices.Second, the USDA translation is a valuable tool for food producers as it helps them to understand the regulations and standards they must comply with to ensure that their products are safe for consumption. This is particularly important forsmall-scale producers who may not have the resources to hire legal experts to help them navigate the complex regulations.Third, the USDA translation helps to address the language barrier that can prevent some consumers from accessing critical information regarding food safety. By making the Food Safety Law available in multiple languages, the USDA ensures that all consumers, regardless of their background, can make informed decisions about the food they eat.The Food Safety Law covers a wide range of areas that are critical to ensuring a safe food supply. These include food labeling, inspection, and testing, as well as standards for food additives and contaminants. The law also provides guidelines for the handling and storage of food, as well as regulations relating to food imports and exports.To enforce the Food Safety Law, the USDA works closely with other federal agencies, including the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The USDA also collaborates with state and local governments, as well as industry groups and consumer organizations, to develop and implement food safety policies and programs.In conclusion, the USDA translation of the Food Safety Law plays a crucial role in ensuring a safe and reliable food supply for all Americans. By providing clear and accessible information, the USDA helps food producers, regulators, and consumers to work together to ensure that the food we eat is healthy, nutritious, and free from harm. As the world continues to grapple with the challenges of food safety, the USDA's translation of the Food Safety Law will remain an indispensable tool in ensuring that our food supply is safe, healthy, and sustainable.。
解读美国新出台的《食品保护计划》
管辖本 国食 品价值高达 ４１０ ７ 亿美元 ．进 口食 品高
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如非 家庭 制作 的方 便食 品 、即食 食 品 的增 加 促 使
的 化学 污染 物 。而这 些致病 因子 随着全 球气 候 变 暖 和 环境 污染 ．还 有继 续增 加 的趋势 。 基 于 以上原 因 ．美 国提 出必须 构建 更 为积 极 和 富 有 战略性 的食 品安 全 防护体 系 。
美国食品防护计划与HACCP
2 美国食品防护计划涉及的内容
ASSURE LOOK EMPLOYEES REPORT THREAT
2.1 确保（ASSURE）
了解的供应商 鼓励的供应商执行食品防护措施 要求给车辆/集装箱/铁路车厢上锁和/或贴封 监控采购原料的卸货
? 关注点 ? 食品安全体系 ? 预防性 ? 发展变化
?请各位专家批评指正 谢谢！
限制员工进入 防止客户进入的设施内的关键区域
2.4 报告 (REPORT)
定期评估安全管理系统的有效性 实施食品防护随机检查 建立和保存记录 评估吸取的教训
2.5 威胁（THREAT）
? 隔离认为已受到影响的任何产品 ? 联系相关执法部门
3 食品防护计划的建立和实施
步骤一：进行食品防护评估
进行评估的区域包括外部安全、内部 安全、加工安全、储存安全、运送 /接收安 全、水/冰的安全、人员安全、邮寄处理安 全等
2.2 监督（LOOK）
实施产品处理系统
追踪原料
将产品标签存放在安全场所，并销毁过期 或废弃产品标签
2.2 监督（LOOK）
限制进入和检查设施
对成品实施追踪 鼓励的仓ห้องสมุดไป่ตู้运营部门执行食品防护措施
2.3 员工（EMPLOYEES）
对员工进行背景核查 了解在车间内工作的人员 制定员工身份识别系统
2.3 员工（EMPLOYEES）
3 食品防护计划的建立和实施
步骤二 : 制定食品防护计划
制定一些经济有效的预防性的操作 计划，将那些易受攻击的可能性降到最 小。
3 食品防护计划的建立和实施
? 步骤三 : 完成食品防护计划
美国《FDA食品安全现代化法案》概述
进口食品占美国食品供应总量的15%，进口新鲜果蔬和海产 进口食品占美国食品供应总量的15%，进口新鲜果蔬和海产 品分别占消费量的60%和80%。 品分别占消费量的60%和80%。
《FDA食品安全现代化法案》立法过程 FDA食品安全现代化法案 食品安全现代化法案》
历经波折，最终通过将众议院提出的《 历经波折，最终通过将众议院提出的《H.R.2571 FDA食品安全现代化法案》和参议院提出的《 FDA食品安全现代化法案》和参议院提出的《S.510 FDA食品安全现代化法案》 FDA食品安全现代化法案》两个版本合二为一的 《H.R. 2571 ENR FDA食品安全现代化法案》，并于 FDA食品安全现代化法案》 2010年12月21日提交美国总统签署。2011年 2010年12月21日提交美国总统签署。2011年1月4日， 奥巴马总统签署了该法案，使之成为美国第111届国 奥巴马总统签署了该法案，使之成为美国第111届国 会第353号法律。 会第353号法律。
《FDA食品安全现代化法案》立法目标 FDA食品安全现代化法案 食品安全现代化法案》
本法案旨在对已经实施了70多年的《 本法案旨在对已经实施了70多年的《联邦食品药品化妆品 法》进行一次“现代化”大变革修订， 进行一次“现代化” ■三大能力提升； ■扩大FDA对国内食品和进口食品安全监督管理权限； ■扩大FDA对国内食品和进口食品安全监督管理权限； ■构建更为积极的和富有战略性的现代化食品安全“多维” 保护体系，妥善解决食品安全和食品防护问题； ■确保美国国家食品供应安全继续走在世界前列。
危害分析和基于风险的预防措施
将危害分析和风险预防控制措施的理念、方法以法律形式强制 应用于食品链的所有企业和所有环节。 除符合HACCP要求的水产品、果汁、以及低酸罐头食品企业按 除符合HACCP要求的水产品、果汁、以及低酸罐头食品企业按 相关法规执行外，其它食品企业的所有者、经营者或负责人， 必须评估可能影响其所生产、加工、包装或存储食品的危害， 确定并采取预防措施将危害的产生降至最低或避免发生，按照 要求保证该食品未经掺杂或者无错误标识，监控上述控制措施 要求保证该食品未经掺杂或者无错误标识，监控上述控制措施 的实施，并留存监控记录。
美国食品防护计划及其经验启示
描述：文章系统地对美国食品防护计划的核心内容、主要特点、实施成效进行了梳理。
在此基础上，结合我国实际，得出了美国食品防护计划对中国的经验启示，以期为进一步完善我国食品防护体系，保障国内食品安全提供参考。
摘要：文章系统地对美国食品防护计划的核心内容、主要特点、实施成效进行了梳理。
在此基础上，结合我国实际，得出了美国食品防护计划对中国的经验启示，以期为进一步完善我国食品防护体系，保障国内食品安全提供参考。
一、引言本文在梳理美国食品防护计划的概念、相关内容、主要特点、实施成效，以及结合我国实际的基础上，得出美国食品防护计划对中国的经验启示，以期为进一步完善我国食品防护体系，保障国内食品安全提供参考。
本文余下章节构成如下：第二节美国食品防护计划的概念及相关内容；第三节美国食品防护计划的发展现状及特点；第四节我国食品防护计划的发展现状及不足；第五节美国食品防护计划对中国的经验启示。
二、美国食品防护计划的概念及相关内容1. 何谓食品防护计划。
食品防护计划是以达到食品防护目的而制定的一系列制度化、程序化措施的书面文件，是食品安全管理体系的一个分支，它建立在全面的食品防护安全评估的基础上，遵循适应不同产品类型和企业实际的原则。
根据美国农业部食品安全检察署（FSIS）发布的一般食品防护计划的范本，食品防护计划主要由下述四部分构成。
首先是外部安全措施，涵盖实体安全、装运与接收安全以及邮件处理安全三个方面，目的是防止人员擅自出入或未经批准的材料进入设施。
其次是内部安全措施，该项措施的目的是在整个生产流程中防止产品受到蓄意污染，具体包括一般性内部安全、屠宰与加工区安全、储存安全、原料、水与冰安全、化学品与危险材料控制安全，以及信息安全六部分。
再次是人员安全措施，包括员工安全、非员工安全和安全培训三部分，该措施旨在确保在任何时候，设施中只有授权人员。
最后是事件应对安全措施，针对产品污染威胁或事件，利用计划中的措施迅速应对，包括调查安全疑虑、应急联系人安全和其他计划安全陈述3方面。
了解美国《食品安全现代化法案》,帮助中国企业更为有效的出口
了解美国《食品安全现代化法案》，帮助中国企业更为有效的出口作者：王翠竹来源：《食品安全导刊》2015年第10期看过《纸牌屋》的人基本了解，美国的法规首先由国会起草，然后发布议案，最后递交到白宫由美国总统签署成为正式法律并写入名为“美国联邦法规”的法典中。
《美国联邦法规》（CFR）涉及环保、刑法等方面的内容，同时也包括了《食品、药品和化妆品法》，它是美国政府执行机构和部门在“联邦公报”（federal register，简称FR）中发表与公布的一般性和永久性规则集成，具有普遍实用性和法律效应。
美国联邦法规关于食品、药品、医疗器械、化妆品、辐射类电子产品等的法规在CFR 21章中均所有体现。
早在1938年，美国总统罗斯福就签署了《食品、药品和化妆品法案》，但是如今，每年仍有4800万美国人因食品安全问题而生病就医、12800人入院治疗，3000人死亡。
频繁发生的食品安全事件，使食品安全受到高度关注，如食品中添加三聚氰胺、水产品中添加非法抗生素等，所以2011年美国总统奥巴马签署了《食品现代化法案》（FSMA），可以说FSMA是70年以来美国专门针对食品方面具有最大变更和改革意义的法案。
美国食品药品管理局（FDA）隶属于于联邦卫生和公共服务部管辖，旨在保护和促进国家公共卫生，其执行的大部分联邦法律都被编入《联邦食品、药品和化妆品法案》，包括：良好生产规范（GMPs）、低酸或者酸化食品（LACF）、产品标签、反生物恐怖法案和《食品现代化法案》（FSMA）。
实际上，FDA更加重视产品上市后的监管，而且FDA会给美国当地进口商施加压力，FSMA的相关规定恰恰使进口商在对制造商的产品品质管控中承担了更多的责任。
FSMA法案包含众多内容——约1000余页，有现行法规、民意与讨论期的法规、近期需要发布的内容等。
众所周知，美国是一个进口大国，80%的原料药、海产品；40%的成品药；近50%的新鲜水果；20%新鲜蔬菜等都需要从美国以外的国家进口。
重要要求《国外供应商确认专案》之最终规则综览
美国食品药品管理局（FDA）提供此译文作为面向广大国际读者的一种服务。
我们希望您觉得此译文对您有用。
虽然本局努力获取尽可能忠于英文原文的译文，但是我们意识到译文不可能如英文原文那么精确、清楚或完整。
本文件的正式版本是英文版。
重要要求：《國外供應商確認專案》之最終規則綜覽當前，關於人類和動物食品進口商的《國外供應商確認專案》(FSVP) 的 FDA 《食品安全現代化法案》 (FSMA) 規則為最終版本，某些企業的合規日期將於 18 個月內開始。
最終規則要求進口商執行某些基於風險的活動，以核實進口至美國的食品已採用符合適用的美國安全標準的方式進行生產。
本規則是 FDA 向行業、消費者團體、機構的聯邦、州、當地、部落以及國際監管相關方、學界以及其他利益相關方進行廣泛外聯的產物。
FDA 於 2013 年 7 月首次提出本規則。
在評論期和大量討論（包括公開會議、網路研討會以及意見聽取會議）過程中獲取意見之後，FDA 已於 2014 年 9 月就擬定的規則制定發佈了一份補充通知。
擬定的修訂版本不僅在確定基於食品和供應商風險的適當確認措施過程中為進口商提供靈活性，同時承認食品中最嚴重的危害物質對公共健康產生的較大風險。
最終規則包含了原始和補充提案中的內容，同時為滿足某些要求增加了較大的靈活性，以更好地體現現代化供應和分銷鏈。
例如，進口商可在某些情況下依據其他實體執行的分析、評估和活動來履行重要的 FSVP 義務，只要此類進口商審閱和評估相應的記錄文件即可。
FDA 負責確保進口商滿足 FSVP 要求，還將提供指導、外聯和培訓。
以下是重要的要求和合規日期。
1.適用範圍•該規則涵蓋哪些人員？o基於 FSVP 之目的，進口商是提供進口至美國的某種產品的美國所有人或承銷人。
如果在入境時，某種食品無美國所有人或承銷人，進口商則是在入境時的承銷人的外國所有人的美國代理或代表，如已簽署的同意聲明中確認的內容所述。
o下文將討論相關的豁免情況。
美FDA发布新的食品防护指南
美FDA发布新的食品防护指南2018年6月20日，美国食品和药物管理局(FDA)发布了《食品安全和现代化法案》(FSMA)之《蓄意掺假法规》(IA)指南草案的第一部分。
该规定旨在指导食品行业降低食品设施暴露于IA的风险，如恐怖主义行为。
与其他针对特定食品或危害的FSMA规定不同，IA需要采取预防措施，以减少所有在FDA注册的食品设施的国内外公司的脆弱性。
关于防护计划的要求这是公司第一次必须提供书面的食品防护计划，需详细说明他们将如何实施这条规则。
FDA局长戈特利布称，“FDA监管范围内的食品企业将被要求制定和实施一项食品防护计划，以识别企业的脆弱环节并制定预防控制措施。
”企业还必须确保控制措施有效。
此举是FDA 的新监管领域。
他将直接与相关方合作，解决食品制造商的担忧。
戈特利布说:“这份指导草案的整体目标，是帮助那些需要采取更多措施来遵守这一规定的制造商，提高透明度和可预测性。
”“我们希望帮助确保新的要求具有成本效益，而不是过于繁重，同时还能保护食品系统。
”在指导文件中，FDA提供了一些食品设施的选择以防止蓄意掺假的发生。
在其中一个部分，该机构建议对潜在员工进行背景调查，看看新员工是否对食品企业构成威胁。
企业也可以选择监测易损活动，如处理散装液体。
运输和接收是另一个需要关注的领域，处理食品储存容器也是如此。
该指南说，每个公司或设施都有责任决定监控的频率，每3年需要一份书面的防御计划。
年底前会有更多的内容发布该规则的第二和第三部分将于今年晚些时候发布。
指南草案的第二部分将侧重于针对食品员工设施和培训的脆弱性评估方法。
指南的第三部分将详细说明纠正措施，包括如何验证设施的系统是否正常工作。
美国FDC法案805条
美国FDC法案805条
根据美国食品药品管理局（FDA）发布的2022年1-3月份拒绝进口产品信息，食品伙伴网进行了统计。
2022年1-3月份我国共有685批次产品被美国FDA拒绝进口，其中遭拒绝进口的食品有168批次。
一季度我国食品遭拒绝进口原因排前三位的分别为：三聚氰胺；全部或部分含有污秽或其他不适于食用的物质；有毒有害物质。
一季度我国食品遭美国拒绝进口的其他原因包括沙门氏菌（2例）、未声明过敏原（1例）、违反FD&C 法案第805 条（7例）、未注册为低酸罐装食品或酸化食品制造商（3例）和外国政府或工厂、仓库或其他机构的所有者、经营者或其代理人拒绝美国检察人员进入（2例）。
关于证据法上的认知，人们可以从古罗马法上的“显著之事实，无需证明”这一法谚中溯及源流。
其中所树立的理念就在于，人类为理性之灵长，在司法程序范围内，为解决纠纷，当某一事项作为待证事实的一部分，而该事项已在此之前，即为一定范围内的人们所感知到显而易见的程度时，司法者自可应以审判职务上的自认的权威对此加以认同，从而赢得了诉讼上的节省，这实际上是社会总体劳动成本的一种节约。
对于这种毋庸争执的事项，在职权主义审判模式下，为职权探知原则下的应尽职权注意或职权调查成为一种必要定式；而在当事人对等辩论模式下，英美法著名学者
如摩根先生和麦考密克先生认为，法院的职权，原在解决当事人间法律关系遭受影响的争执。
此种争执，或为法律问题，或为事实问题，或两者兼而有之。
食品伙伴网提醒各出口企业：应严格控制食品在运输过程中的质量状况，避免由于长距离运输出现食品腐烂变质的情况；针对三聚氰胺问题，企业应做好原辅料的控制；同时，也要注意产品中有毒有害物质的存在。
看新法框架下美国食品安全保护策略
包 括
食 源 性疾 病 、 葺意 污 染 以 及 Ｆ ＤＡ“ Ｉ ｌ Ｌ ｜ Ｊ 等 方 而 的 挑 战， 提 … Ｊ 改革思路 ｆ １ Ｉ 汁 划 。２ ０ １ １ 年１ 月４Ｈ，美 川 … Ｊ 食ｆ ｌ 『 【 Ｉ Ｉ 安 伞现代化法》 （ 以 Ｆ简 称 “ 新法” ）。 新 法 埘 荚 同 食 品 安 伞 １ ’ ： 体 系进 Ｊ ｒｍ 人变 ， 形 成 了 以预 防 、 ｌ 、反 为
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看新法框架下美国食品安全保护策略
■ 文ｌ 宦萍 珠海出入境检验检疫局
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美国FDA《食品保护计划》(珠海局翻译)20080408
美国食品药品管理局食品保护计划翻译：宦萍、刘语蓉、莫晓凤、王冲审校：高彦生、宦萍、刘语蓉、莫晓凤、王冲珠海出入境检验检疫局译2008年3月当今，美国消费者在食品选购方面拥有着空前的便利，但在确保食品安全方面，我们也面临着新的挑战。
《食品保护计划》将通过实施预防、干预和反应等系列战略措施，确保整个食品供应链中每个环节的安全。
美国卫生与公众服务部部长：Michael O.Leavitt作为医师和食品药品委员，保护美国食品供应安全是我非常重要的职责。
美国是世界上拥有最安全食品供应的国家之一，但形势在不断变化，而且我们也认识到食品的安全性可以得到不断的提高，随着新的食品原料的出现、食品生产方法和销售的不断发展，食品进口量随着消费者的需求而不断增长，我们有必要采取措施防止食品受到蓄意或无意的污染。
美国食品药品管理局必须与时俱进，采取措施确保美国国家食品供应安全居世界前列。
几年来，美国食品药品管理局已经采取了很多措施应对因微生物及其他原因造成的国产及进口产品安全危害，并指导生产企业实施鲜切果蔬安全生产操作。
同时，食品药品管理局也在努力提高食品防护意识并做好各项准备工作，而这些只是我们为提高食品安全和防护所做的部分工作。
近年来，世界范围内的食品召回使我们更加深刻地认识到食源性疾病的危害性。
2006年，受污染的花生酱导致了300多人发病，至少50人住院治疗；受污染菠菜导致了206人发病，3人死亡，100多人住院治疗；有关猫狗的肾脏损伤和死亡的报告引发了100多个品牌宠物食品的召回。
对于每次突发事件，食品药品管理局都能快速做出反应，最大限度地降低危害。
食品药品管理局调查官员对每个事件都进行溯源，并及时对问题产品采取下架处理。
食品药品管理局将继续为保护美国食品安全作出努力，防止食品安全事件的发生。
《食品保护计划》的制定和实施，将促进美国食品安全保护工作。
本计划引入了先期介入（forward-oriented）的理念，即应用科学和现代信息技术提前确定潜在的危害。
2024年珠海市食品安全监督抽检计划
2024年珠海市食品安全监督抽检计划(中英文版)英文文档：Title: 2024 Zhuhai Food Safety Supervision and Inspection PlanContent:The Zhuhai Food Safety Supervision and Inspection Plan for 2024 aims to ensure food safety and protect public health.The plan focuses on key food categories, including processed foods, dairy products, meat, vegetables, and fruits.In 2024, the Zhuhai Food and Drug Administration will conduct random inspections of food production and processing enterprises, food markets, and food sales outlets.The inspections will cover aspects such as food production qualifications, food storage and transportation conditions, food labeling, and the presence of prohibited additives.In addition, the plan emphasizes the importance of monitoring food safety risks.The Zhuhai Food and Drug Administration will establish a food safety risk monitoring system, which will include regular sampling and testing of food products, as well as the analysis of food safety incidents and their causes.The Zhuhai Food Safety Supervision and Inspection Plan for 2024 also emphasizes the strengthening of legal sanctions for food safety violations.The plan states that those who violate food safety regulationswill face strict legal consequences, including fines,没收illegal profits, and even criminal penalties.Overall, the Zhuhai Food Safety Supervision and Inspection Plan for 2024 demonstrates the city"s commitment to ensuring food safety and protecting public health.中文文档：标题：2024年珠海市食品安全监督抽检计划内容：2024年珠海市食品安全监督抽检计划旨在确保食品安全，保护公众健康。
美国新HACCP法规对过敏原的操纵及启发
美国新HACCP法规对过敏原的操纵及启发近几年美国食物平安相关法规不断完善，对过敏原的相关要求不断提升，在FDA最新公布的《适用于人类食物的良好操作标准、危害分析及基于风险的预防性操纵方法》（以下简称《人类食物预防性操纵方法》法规），将过敏原操纵上升到了一个新高度，本文在对美国最新法规进行分析的基础上，总结提出其对我国食物平安的借鉴意义。
1 过敏原及美国过敏原标准及要求食物过敏原一样为相对分子质量的蛋白质或糖蛋白，这些过敏原具有抗高温加热、酸稳固性强等特性，很难通过加热或消化的方式去除。
目前已证明有170多种食物可能引发过敏体质人群产生不良反映。
过敏反映(hypersensitivity)又称变态反映，是一类异样的病理性免疫应答，其结果可引发多种临床疾病，如肠绞痛、口腔(粘膜)变态反映综合征等疾病，严峻时乃至致使死亡。
将食物中的过敏原成份在标签上进行明确标注，一直被以为是操纵过敏原危害的最有效手腕。
上世纪90年代至今，美国出台了一系列法规来明确过敏原标注要求。
1996年6月，美国发布通知要求食物生产企业在食物标签上声明食物中的过敏原信息。
2004年8月，美国通过了《食物过敏原标识和消费者爱惜法案》，这是美国关于食物过敏原标签的一部大体法规，规定了八大类食物过敏原及含有某些食物过敏原的食物的标识，要求所有非原始农业商品的食物，和所有含有过敏原的食物，应在标签上清楚标注出派生过敏原的食物种类的名称。
尔后，在2005年到2007年间，美国陆续发布了无麸质食物的标注指南草案和勘误表和要紧食物过敏原和麸质的限量设立方式。
在肉类、蛋类等专业性法规中也对其标签标识做出了规定。
在2020年FDA发布的《水产品HACCP 指南》中，过敏原已被推荐作为CCP点进行预防操纵。
2 新公布的《人类食物预防性操纵方法》法规对过敏原的操纵要求《人类食物预防性操纵方法》法规是美国《食物平安现代化法》（FSMA）的首个配套法规，其概念中表现的基于风险的预防操纵，包括了聚焦食物平安、预防性而非反映性、以GMP 等为基础、将食物平安危害降至可同意水平等特点，能够说，从原理上与HACCP超级相似。
美国食品安全全新体系简介
美国食品安全体系简介美国食品安全体系简介美国旳食品安全体系以强有力旳,灵活旳,以科学为基本旳法律和食品产业有义务生产安全食品旳法律责任为基本。
是由联邦政府负责食品安全旳部门,在地方政府相应部门参与下,构成旳一套综合旳和有效旳体系。
近年来法令旳贯彻以及食品安全系统旳运作赢得了公众对美国旳食品安全非常高旳信心。
负责保护消费者旳重要联邦管理机构涉及健康和人类服务部 (DHHS)食品和药物管理局 (FDA), 美国农业部(USDA)食物安全检查服务中心 (FSIS)和动植物检查检疫服务中心(APHIS),以及美国环保署（EPA）。
财政部旳海关署协助管理机构按照规定执行对进口货品旳检查及临时查扣。
多数政府机构负有食物安全旳使命，涉及于它们旳研究，教育,避免,监测,原则制定,及/或应急事件反映行动中,这些部门涉及健康和人类服务部旳疾病控制中心(CDC)以及国家卫生研究院 (NIH)，美国农业部旳农业研究服务部 (ARS)，国家研究,培训,拓展合伙服务部 (CSREES)，农业市场服务部 (AMS)，经济研究服务部 (ERS)，粮食检查,包装和畜栏管理局 (GIPSA)，和美国法典办公室，以及商业部旳国家海洋渔业服务部 (NMFS)。
美国食品药物管理局承当保护消费者避免受到不纯,不安全,以及虚假标记食品危害旳责任，但不涉及食品安全检查服务中心负责管理旳范畴。
食品安全检查服务中心负责保证肉类,及禽类河蛋类产品旳安全卫生,有益健康以及标记旳精确性。
美国环保署旳职责涉及保护公共健康和环境不受到农药旳危害以及发展治理害虫旳更安全措施。
在美国，食品或饲料中如果具有未经美国食品药物管理局批准旳食品添加剂或药物残留量超标；或者具有美国环保署不容许旳农药残留物或是农药残留物超过了规定旳容许量，那么该食品或饲料是不会被容许合法上市销售旳。
动植物检查检疫服务部在美国食品管理网络中扮演旳重要任务是保护动植物免受虫害和疾病旳侵蚀。
美国食品药物管理局,动植物检查检疫服务部,食品安全检查服务部,和美国环保总署根据现行旳食品安全和环境法律对通过生物技术开发旳植物,动物,和食品进行管理对美出口化妆品须知在美国，管理化妆品旳法律根据重要是《食品、药物和化妆品法》（FDCA）、《良好包装和标签法》（FPLA）和其他合用法规。
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美国食品药品管理局食品保护计划翻译：宦萍、刘语蓉、莫晓凤、王冲审校：高彦生、宦萍、刘语蓉、莫晓凤、王冲珠海出入境检验检疫局译2008年3月当今，美国消费者在食品选购方面拥有着空前的便利，但在确保食品安全方面，我们也面临着新的挑战。
《食品保护计划》将通过实施预防、干预和反应等系列战略措施，确保整个食品供应链中每个环节的安全。
美国卫生与公众服务部部长：Michael O.Leavitt作为医师和食品药品委员，保护美国食品供应安全是我非常重要的职责。
美国是世界上拥有最安全食品供应的国家之一，但形势在不断变化，而且我们也认识到食品的安全性可以得到不断的提高，随着新的食品原料的出现、食品生产方法和销售的不断发展，食品进口量随着消费者的需求而不断增长，我们有必要采取措施防止食品受到蓄意或无意的污染。
美国食品药品管理局必须与时俱进，采取措施确保美国国家食品供应安全居世界前列。
几年来，美国食品药品管理局已经采取了很多措施应对因微生物及其他原因造成的国产及进口产品安全危害，并指导生产企业实施鲜切果蔬安全生产操作。
同时，食品药品管理局也在努力提高食品防护意识并做好各项准备工作，而这些只是我们为提高食品安全和防护所做的部分工作。
近年来，世界范围内的食品召回使我们更加深刻地认识到食源性疾病的危害性。
2006年，受污染的花生酱导致了300多人发病，至少50人住院治疗；受污染菠菜导致了206人发病，3人死亡，100多人住院治疗；有关猫狗的肾脏损伤和死亡的报告引发了100多个品牌宠物食品的召回。
对于每次突发事件，食品药品管理局都能快速做出反应，最大限度地降低危害。
食品药品管理局调查官员对每个事件都进行溯源，并及时对问题产品采取下架处理。
食品药品管理局将继续为保护美国食品安全作出努力，防止食品安全事件的发生。
《食品保护计划》的制定和实施，将促进美国食品安全保护工作。
本计划引入了先期介入（forward-oriented）的理念，即应用科学和现代信息技术提前确定潜在的危害。
食品药品管理局通过在危害发生前最大限度地进行预防、在食品生产体系的关键点强化干预力度、提高在发现问题时的快速反应能力等措施，为美国食品供应安全构建保护框架。
食品药品委员、医学博士：Andrew C.von Eschenbach目录I．摘要 (1)II. 前言 (3)III. 机遇和挑战 (5)人口变迁和消费倾向 (5)人口流动性 (6)便利趋势 (6)消费模式 (6)全球食品供应 (7)新的威胁 (8)新的食源性病原体 (8)蓄意污染 (9)交流 (9)Ⅳ. 措施概述 (10)要素 (10)预防——食品安全从源头抓起 (11)干预——当风险被确认时验证预防的效果，并予以干预 (11)反应——快速正确反应 (12)横切原则 (12)1. 重点关注产品从生产到消费整个生命周期的风险 (12)2. 锁定目标，将风险降低到最小 (13)3. 应对无意污染和蓄意污染 (13)4. 利用科学和现代技术体系 (14)Ⅴ. 综合计划 (14)要素1：预防 (14)1.1强化企业预防食源性疾病的责任 (15)1.2食品敏感环节的确定和风险评估 (18)1.3 增进了解，采取有效的缓解措施 (19)要素2：干预 (20)2.1基于风险性进行重点抽样和检验 (20)2.2 基于风险分析加强监管 (23)2.3提升对食品体系中污染指示“信号”的监测能力 (25)要素3：反应 (26)3.1提高即时反应的能力 (27)3.2加强与公众、行业和其他利益相关方的风险交流 (29)Ⅵ. 提高信息技术 (30)Ⅶ. 结语 (31)I．摘要为应对国产及进口食品安全（food safety）和食品防护（food defense）问题，美国食品药品管理局（Food and Drug Administration, FDA）启动了《食品保护计划》（Food Protection Plan）。
该计划与FDA《进口安全行动计划》（Administration’s Import Safety Action Plan）相结合，拟通过一整套综合策略付诸实施：．重点关注食品从生产到消费整个生命周期的风险管理．锁定目标以最大限度地降低风险．应对蓄意和无意的食品污染．应用科学和现代化技术体系FDA综合策略的三大保护要素预防：预防食源性污染．强化企业预防食源性疾病的责任．确定食品敏感环节并进行风险评估．加强理解并实施有效的风险降低措施干预：在食品供应链的关键环节实施干预．重点关注基于风险的抽样和检测．基于风险分析加强监控．提升对食品污染指示“信号”的监测能力反应：快速反应降低危害．加强即时反应．加强与公众、企业及其他利益相关方的风险交流FDA认识到有必要与国会协作采取一些改革措施，改善国家食品供应安全状况。
《食品保护计划》明确了FDA所应采取的管理措施，同时建议修订法律，以加强FDA继续保护美国人民免遭食源性疾病危害的能力。
修订法律，增加对FDA的职能授权，以提供更多的保护预防食源性污染．允许FDA有权要求采取预防措施，防止恐怖分子或犯罪分子在食品链的最敏感环节实施人为蓄意掺假．授权FDA发布针对高风险食品的附加预防控制措施．要求食品企业每两年更新其在FDA的注册，允许FDA调整注册目录在食品供应链的关键点实施干预．授权FDA认可高资质的第三方检测机构开展自愿性食品检测．对于达不到动态药品生产管理规范（Current Good Manufacturing Practices , cGMPs）要求的企业实行新的复检费用收取标准．授权FDA对指定的高风险货物要求提供进口电子证书．为加强FDA对出口产品的监管，提高美国企业产品出口能力，允许收取新的食品和动物饲料出口证书费．授权FDA在其查验工作被延迟、限制或拒绝时，可对国内和进口食品采取同等的处理措施快速反应降低危害．授权FDA在食品自愿召回无法有效实施时，可发布食品强制召回令．授权FDA在紧急事件发生期间深入了解相关食品记录FDA拟进一步加强信息技术能力以满足FDA实施《食品保护计划》的需要。
未尽事宜请通过以下方式进行联系：Kari BarrettSenior Advisor, Food Protection TeamRoom 14B-175600 Fishers LaneRockville, MD 20857Phone 301.827.9831Email: FoodProtection@可登录网址/oc/initiatives/advance/food/plan.html查看本计划文档，也可通过/oc/initiatives/advance/food/plan.pdf 下载本计划的PDF文档。
如需查询FDA其他有关保护国家食品供应的计划，请登录http://www. /oc/initiatives/advance/food.html。
II. 前言在美国，人们每天都要出外就餐、购买食品和烹饪家庭膳食。
每个美国人都希望所有的食品都是安全的，而FDA在确保流通市场上的食品安全发挥着重要的作用。
FDA负责美国大多数食品的安全工作，约占美国流通食品总数的80%，包括除肉类、禽类和加工蛋制品以外的所有食品，而肉类、禽类和加工蛋制品则由美国农业部负责。
2007年5月，美国卫生与公众服务部（Health and Human Services, HHS）部长Michael O.Leavitt和食品药品委员Andrew C. von Eschenbach责成FDA 制订全面、综合性的行动计划——《食品保护计划》，以保护美国食品供应免遭蓄意和无意污染。
该计划旨在利用科学和现代信息技术确定潜在危害，并在危害发生之前采取措施。
这种前瞻性工作的基础是进一步强化预防。
5种食源性疾病逐年相对发生率（以1996～1998年的数据作为基数，按实验室确诊的病例计）美国疾病预防控制中心（Centers for Disease Control and Prevention, CDC）通过食品网络计划（/foodnet）对食源性致病性微生物引起的疾病情况和发展趋势进行了持续的监测。
上图反映了近年来在减少食源性疾病方面所取得的进展。
除弧菌和产志贺毒素大肠杆菌O157导致的食源性疾病在最近几年有上升趋势外，其他几种病原微生物相关的病例数都相对稳定或有一定下降，说明仍需要更进一步的做好食源性疾病的防控工作。
根据与这5种病原微生物相关的病例数绘制，其感染途径并不局限于食源性，且包括了不受FDA监管的食品。
（资料来源：美国疾病预防控制中心）《食品保护计划》拟通过实施安全性措施，应对食品从生产、销售到消费整个生命周期中的风险。
该计划促使FDA首先将工作的重点放在预防问题的发生上，然后应用基于风险的干预措施确保预防措施得到有效实施。
一旦发现食品、饲料受到污染，或者对人或动物构成威胁，则要求迅速作出反应。
FDA在《食品保护计划》中的总体工作方案主要围绕预防、干预和反应等三个要素。
“预防”是指强化企业责任，从源头预防问题的出现。
与企业和其他利益相关方一起全面审查食品供应的敏感环节，提出和实施风险降低措施，从而使FDA能更好地应对关键薄弱环节。
“干预”是指在风险分析的基础上重点在食品供应链的高风险环节进行抽样、检验和监督。
这些干预措施必须能够验证所采取的预防措施是否执行到位、正确有效。
“反应”是指通过提高速度和效率，加强FDA的应急反应能力。
包括在突发事件发生时和发生后，FDA与其他联邦部门，州、地方政府部门以及企业开展良好的交流。
无论食品污染是源于蓄意还是无意，都有必要实施快速反应，并与消费者和其他利益相关方进行充分交流。
这种交流应侧重如何识别问题产品以及让公众了解什么产品是安全的。
FDA肩负着通过实施《食品保护计划》来加强国家食品保护体系的重任。
该计划的设计策略和相关配套活动均基于科学并与二十一世纪科技的应用相结合。
《食品保护计划》的适用范围1. 适用于人或动物消费的食品2. 针对国产和进口产品3. 涵盖食品安全（无意污染）和食品防护（蓄意污染）FDA监管约80%的美国食品供应．FDA管辖每年价值约4170亿美元的国产食品和价值490亿美元的进口食品 [1]。
．FDA监管13.6万多家注册的国内食品企业（包括4.4万多家美国食品生产和加工企业，约11.3万个美国食品仓库，包括储存仓和有升降机设备的粮仓）[2]。
．FDA、州或地方主管机构管辖超过200万家的农场，大约93.5万个餐馆和机构的食品服务点，11.4万个超市、杂货店和其他食品批发店 [3]。
FDA 向州及地方协作部门提供指南、法规模式及其他技术帮助。
．约18.9万家在FDA注册的境外企业，生产、加工、包装和储存供美消费食品。